, Oct. 4
/PRNewswire/ -- Peptimmune, Inc. announced today that it has filed a technically focused Citizen Petition requesting that the FDA not approve any application for a generic version of Copaxone® [glatiramer acetate injection] (Teva Pharmaceuticals).
"We feel that it is important for the FDA to have access to Peptimmune's data resulting from our characterization of Copaxone using proprietary methods when considering ANDA applications for generic forms of glatiramer acetate. We believe that manufacturers of any purported generic version of Copaxone need to demonstrate biological equivalence using state of the art methods. Most importantly, this extensive biological characterization that we have developed can serve to further guarantee the safety in multiple sclerosis patients of any purported generic version of Copaxone," stated Thomas P. Mathers, President and Chief Executive Officer of Peptimmune.
The Citizen Petition provides data that highlights several key points for the FDA's consideration:
- Comparative pharmacokinetic (PK) studies with a state of the art method should be required to demonstrate bioequivalence of a purported generic Copaxone
- The demonstrated bioavailability of Copaxone is linearly correlated to its direct effect on the innate immune system
- Pharmacodynamic (PD) studies with state of the art methods are just as important as PK studies due to Copaxone's potent effect on the innate immune system
- Copaxone is a pro-drug which makes the demonstration of bioequivalence very difficult for a purported generic copy
Eric H. Zanelli, PhD, Vice President of Research and Development remarked that, "The safety and efficacy of any proposed generic copy of such a complex drug cannot be guaranteed by physicochemical characterization only. Demonstration of bioequivalence for a generic copy of Copaxone should include the comparative PK and PD studies proposed in the Citizen Petition. Our studies demonstrate a direct correlation between Copaxone serum exposure and activation of the innate immune system. Controlling this relationship in particular is critical to ensure safety and therapeutic effect of any generic copy of Copaxone. The effect of Copaxone cannot just be simply explained by induction of regulatory T cells; its effect on antigen presenting cells is just as important. Systemic exposure of Copaxone facilitates the direct effect on monocyte activity, perhaps even in the brain. If a generic manufacturer primarily limits its characterization of a generic copy to comparative antibody responses or T cell responses they could be significantly underestimating the copy's biological effects."
The Citizen Petition is available for download at www.peptimmune.com/news.
About Multiple Sclerosis
Over 400,000 Americans have multiple sclerosis (MS), and MS may affect over 2.5 million individuals worldwide. MS is an autoimmune disease in which the individual's immune system responds against multiple components of nerve-insulating myelin. The effects of these immune-mediated attacks can range from relatively benign to somewhat disabling to devastating, as communication between the brain and other parts of the body is disrupted.
Peptimmune, Inc. is a privately held clinical stage biotechnology company focused on the development of PI-2301, a second-generation peptide copolymer from a similar compound class as Copaxone. PI-2301 has shown to be more potent and effective than Copaxone in treating disease models for multiple sclerosis. The Company plans to continue developing this promising compound by initiating a Phase II study in relapsing remitting multiple sclerosis patients later this year. Current investors include New Enterprise Associates, MPM Capital, MPM/Novartis Strategic Fund, Hunt Bioventures, Boston Medical Investors, Silicon Valley Bank Capital, and Genzyme Corporation.
SOURCE Peptimmune, Inc.